Aceto GmbH (Hamburg)

Quality Management

Quality Management

  • Documented processes assure quality of products and services for APIs at Aceto GmbH according to Part II of the EU GMP guidelines ICH Q7A.
  • Quality Unit independent from product and sales management
  • Supplier qualification system.
  • Full traceability of products and individual batches; corresponding documents are retained and available for 10 years
  • Quality assurance agreements upon request
  • Steady improvement of the quality management systems
  • Own laboratory and having co-operation with accredited external laboratories. 

Official Permission GMP

An import permission for Active Pharmaceutical Ingredients (APIs) of animal origin in accordance with section 72 of the German Drug Law (AMG) has been granted more than 10 years ago and has been extended in December 2008 to include APIs of microbial origin. Aceto complies with GMP regulations for importers and distributors of APIs.

Official Permission GDP

A Wholesale Permission for human and veterinary medicinal products according to section 52a of the German Drug Law (AMG) has been granted by the responsible German authority in May 2005. Aceto operates in compliance with EU guideline 94/C63/03 (Good Distribution Practice).
  • Suitable and superintended warehouses for all distributed product
  • Sampling of products under laminar flow (class 100)
  • Separate area under lock and key for rejected products
  • Physical separation of active pharmaceutical ingredients and fine chemicals
  • Transport and handling under adequate conditions
  • Continuous temperature and humidity monitoring in all warehouses
  • Cool storage area 2 - 8°C for temperature sensitive products
  • Pest control measures in the warehouses
  • Avoidance of contamination
  • First in First Out (FIFO) stock rotation system

Support for our Customers

It is Aceto's policy to provide full technical and regulatory support side by side with our customers.
  • Competent, experienced personnel with degrees in pharmacy and chemistry takes care of technical aspects of projects
  • GMP audits of suppliers by Aceto auditors with industry experience
  • Review of drug master files, technical packages, site master files and similar documentation
  • Selection of suitable partners for each individual project
  • Evaluation of patent status for products and processes
  • Regulatory intelligence: Steady monitoring of regulatory environment (ICH, CPMP, CVMP, WHO, PIC/S guidelines, HACCP, REACH)

Vendor Support

  • Consulting services for suppliers
  • Support to producers in preparing Drug Master Files (CTD format) and Application Dossiers for Certificates of Suitability
  • Writing of Quality Overall Summaries on DMFs and Application Dossiers for CoS
  • Assistance in answering questions from health authorities
  • Improvement of working safety
  • Regulatory intelligence: Steady monitoring of regulatory environment (ICH, CPMP, CVMP, WHO, PIC/S guidelines, HACCP, REACH)

Strict Compliance

Our goal is compliance with all Health, Safety, Transport and Environmental Regulations 100% of the time.
  • Establishing Material Safety Data Sheets for all products inhouse
  • Trained and examined safety advisers for road (ADR) and air (IATA) transportation
  • Permission to store dangerous goods with good capacities
  • Approval for storage of materials from water endangering classes 1 to 3
  • Warehouses in compliance with EU and national environmental legislation
  • Proper waste disposal of rejected or expired materials
  • Compliance with all import and export regulations (e.g. dual use, GÜG, ...)
  • Licence for narcotics
It is Aceto's policy to provide full technical and regulatory support to our suppliers and customers. Since 1996 we have had certified total quality management systems in place.Our goal is compliance with all health, safety, transport and environmental regulations 100% of the time and we are committed to continually improving the quality of our service

Quality Management System test

  • Documented processes according to ISO9001:2015 assure quality of products and services for intermediates and speciality chemicals at Aceto GmbH.
  • Quality Unit independent from Product Management. 
  • Supplier qualification system.
  • Full traceability of products and individual batches, corresponding documents are retained and available for 10 years.
  • Quality assurance agreements upon request.
  • Steady improvement of the quality management system.

Support Through The Entire Supply Chain

  • Competent and experienced personnel with degrees in chemistry takes care of regulatory and technical aspects of projects.
  • Audits of suppliers by Aceto auditors with industry experience.
  • Selection resp. qualification of suitable suppliers for each individual project is implemented in our quality management system.
  • Regulatory intelligence: permanent monitoring of the regulatory environment and strict compliance with all import and export regulations (e.g. Dual Use, BtMG, GÜG, GefStoffV, REACH etc.).
  • Consulting services for suppliers/producers.

Strict Compliance

  • Inhouse preparation of material safety data sheets for all products according to 1907/2006/EG, Article 31.
  • Trained and examined safety advisers for road (ADR) and air (IATA) transportation.
  • Permission to store dangerous goods with good capacities.
  • Approval for storage of materials from water endangering classes 1 to 3.
  • Proper waste disposal of rejected materials.

Warehouse

  • ISO9001 certified, suitable and superintended warehouse for all distributed products.
  • Warehouses in compliance with EU and national environmental legislation.
  • Transport and handling under adequate conditions.
  • Continuous temperature and humidity monitoring in all warehouses.
  • Pest control measures in the warehouses.
  • First in first out (FIFO) stock rotation system.

Quality Management System

  • Documented processes assure quality of products and services for Health Ingredients and Food / Feed additives at Aceto GmbH according to HACCP.
  • Quality Unit independent from product and sales management.
  • Supplier qualification system.
  • Full traceability of products and individual batches; corresponding documents are retained and available for 10 years.

Official Permissions

  • Documented processes assure quality of products and services for Health Ingredients and Food / Feed additives at Aceto Health Ingredients GmbH according to HACCP.
  • Quality Unit independent from product and sales management.
  • Supplier qualification system.
  • Full traceability of products and individual batches; corresponding documents are retained and available for 10 years.
  • Organic-certified
  • MSC- and FOS-certified

Support of Customers

  • Competent, experienced personnel with degrees in biology and chemistry takes care of regulatory and technical aspects of projects.
  • Regulatory intelligence: steady monitoring of regulatory environment (EFSA, HACCP, REACH).
  • Audits of suppliers.

Support of Vendors

  • Consulting services for suppliers.
  • Improvement of working safety.
  • Regulatory intelligence: steady monitoring of regulatory environment (EFSA, HACCP, REACH).

Strict Compliance

  • Establishing Safety Data Sheets for all products in-house.
  • Trained and examined safety advisers for road (ADR) and air (IATA).
  • Approval for storage of materials from water endangering classes 1 to 3.
  • Warehouses in compliance with EU and national environment legislation.
  • Proper waste disposal of rejected materials.
  • Compliance with all import and export regulations.

Warehouse

  • ISO9001 certified, suitable and superintended warehouse for all distributed products.
  • Warehouses in compliance with EU and national environmental legislation.
  • Transport and handling under adequate conditions.
  • Continuous temperature and humidity monitoring in all warehouses.
  • Pest control measure in the warehouse.
  • First in first out (FIFO) stock rotation system.
It is Aceto's policy to provide full technical and regulatory support to our suppliers and customers. Since 1996 we have had certified total quality management systems in place.Our goal is compliance with all health, safety, transport and environmental regulations 100% of the time and we are committed to continually improving the quality of our service.

Quality Management

  • Documented processes according to ISO9001:2015 assure quality of products and services for intermediates and speciality chemicals at Aceto GmbH.
  • Quality Unit independent from Product Management.
  • Supplier qualification system.
  • Full traceability of products and individual batches, corresponding documents are retained and available for 10 years.
  • Quality assurance agreements upon request.
  • Steady improvement of the quality management system.

Support Through The Entire Supply Chain

  • Competent and experienced personnel with degrees in chemistry takes care of regulatory and technical aspects of projects.
  • Audits of suppliers by Aceto auditors with industry experience.
  • Selection resp. qualification of suitable suppliers for each individual project is implemented in our quality management system.
  • Regulatory intelligence: permanent monitoring of the regulatory environment and strict compliance with all import and export regulations (e.g. Dual Use, BtMG, GÜG, GefStoffV, REACH etc.).
  • Consulting services for suppliers/producers.

Strict Compliance

  • Inhouse preparation of material safety data sheets for all products according to 1907/2006/EG, Article 31.
  • Trained and examined safety advisers for road (ADR) and air (IATA) transportation.
  • Permission to store dangerous goods with good capacities.
  • Approval for storage of materials from water endangering classes 1 to 3.
  • Proper waste disposal of rejected materials.

Warehouse

  • ISO9001 certified, suitable and superintended warehouse for all distributed products.
  • Warehouses in compliance with EU and national environmental legislation.
  • Transport and handling under adequate conditions.
  • Continuous temperature and humidity monitoring in all warehouses.
  • Pest control measures in the warehouses.
  • First in first out (FIFO) stock rotation system.